Product image of Montelukast Aurobindo (Montelukast) supplied by GNH India

Montelukast Aurobindo

Active Ingredient:
Montelukast
Origin:
EU

Montelukast Aurobindo (Montelukast)

Montelukast, the active ingredient in Montelukast Aurobindo, is a leukotriene receptor antagonist presented as an oral tablet for systemic use. It is employed to manage asthma, allergic rhinitis, and exercise‑induced bronchoconstriction in adults and children as directed by a healthcare professional.

GNH India supplies Montelukast Aurobindo as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide. The company adheres to stringent quality standards and provides regulatory documentation for each batch. Products are shipped under controlled conditions to ensure integrity upon arrival.

Manufacturer / TM Owner

Aurobindo Pharma (Italia) S.R.L.

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Indications & Clinical Uses

Montelukast acts on the leukotriene pathway to control airway inflammation and bronchoconstriction.

  • Asthma (maintenance therapy): reduces frequency of symptoms and improves lung function in patients with persistent asthma.
  • Allergic rhinitis: alleviates nasal congestion, sneezing and itching associated with seasonal or perennial allergic rhinitis.
  • Exercise‑induced bronchoconstriction: prevents narrowing of the airways that can occur during or after physical activity.

How It Works

  • Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1 on airway smooth‑muscle cells, mast cells and eosinophils. By antagonizing this receptor, it prevents leukotriene‑mediated bronchoconstriction, vascular permeability and inflammatory cell recruitment, thereby reducing airway edema and hyper‑responsiveness associated with asthma and allergic diseases.

Side Effects

Montelukast may be associated with a range of adverse reactions, most of which are mild and transient.

Common Side Effects

  • Headache: mild to moderate pain often occurring early in therapy.
  • Upper respiratory tract infection: symptoms such as sore throat or nasal congestion.
  • Abdominal pain: discomfort or cramping in the stomach area.
  • Diarrhea: loose stools that may resolve without intervention.
  • Cough: occasional dry or productive cough.

Serious or Rare Side Effects

  • Allergic reactions: rash, urticaria, or angioedema requiring medical attention.
  • Neuropsychiatric events: mood changes, depression, or suicidal thoughts.
  • Hepatotoxicity: elevated liver enzymes or hepatitis.
  • Stevens‑Johnson syndrome: severe skin blistering and mucosal involvement.
  • Anaphylaxis: life‑threatening systemic allergic response.

Precautions & Warnings

When prescribing Montelukast, clinicians should consider several safety and handling precautions.

  • Indication verification: ensure the drug is appropriate for asthma, allergic rhinitis or exercise‑induced bronchoconstriction.
  • Age considerations: use in children only under medical supervision and according to approved pediatric dosing.
  • Hepatic function: monitor patients with liver impairment as metabolism occurs hepatically.
  • Neuropsychiatric monitoring: observe for mood alterations, depression or suicidal ideation.
  • Drug interactions: review concomitant medications for potential interactions.
  • Store at ambient temperature: keep tablets in the original container, protect from moisture and excess heat.

Avoid Interactions

Montelukast can interact with other medicines, affecting its efficacy or safety.

Major Interactions (Avoid)

  • Phenobarbital, carbamazepine, phenytoin: strong enzyme inducers that may reduce montelukast plasma concentrations.
  • Ritonavir or other potent CYP3A4 inhibitors: may increase exposure and risk of adverse effects.

Moderate Interactions (Monitor Closely)

  • Warfarin: possible alteration of anticoagulant effect; monitor INR.
  • Fluconazole: moderate CYP3A4 inhibition may raise montelukast levels.
  • Salmeterol or other long‑acting β‑agonists: combined use may enhance bronchodilation but requires clinical assessment.
  • Antidepressants (e.g., fluoxetine): monitor for neuropsychiatric side effects.

Frequently Asked Questions

Montelukast Aurobindo is indicated for the long‑term management of persistent asthma, for relief of symptoms associated with allergic rhinitis, and for prevention of exercise‑induced bronchoconstriction. It works by targeting the leukotriene pathway that contributes to airway narrowing and inflammation.

Montelukast selectively blocks the cysteinyl leukotriene receptor CysLT1 on cells in the respiratory tract. By preventing leukotrienes from binding, it reduces bronchoconstriction, vascular leakage, and inflammatory cell recruitment, which together lessen airway swelling and hyper‑responsiveness.

The appropriate dose of Montelukast Aurobindo is set by the prescribing clinician based on the patient’s age, weight, specific indication, and overall clinical response. Dosage recommendations are provided in the product labeling and must be individualized for each patient.

Safety data for Montelukast in pregnancy and lactation are limited. The drug should only be used if the potential benefit to the mother outweighs any possible risk to the fetus or infant, and the decision must be made by a qualified healthcare professional.

To place an order, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details and any necessary import documentation.

Montelukast and inhaled corticosteroids act on different aspects of airway disease. Montelukast targets leukotriene‑mediated inflammation, while inhaled steroids broadly suppress airway inflammation. In many treatment plans, Montelukast is used as an add‑on therapy to improve control, especially for patients with allergic components or exercise‑related symptoms.

Montelukast Aurobindo tablets should be stored at ambient temperature, below 25 °C, in the original packaging. Protect them from moisture, direct sunlight and excessive heat to maintain potency throughout the shelf‑life.

The medication is taken orally, usually as a whole tablet with or without food, according to the prescriber’s instructions. Swallow the tablet whole; do not crush, chew, or split it unless specifically advised by a healthcare professional.

Serious adverse events, although rare, include severe allergic reactions such as anaphylaxis, Stevens‑Johnson syndrome, and neuropsychiatric effects like depression, mood changes or suicidal thoughts. Patients should seek immediate medical attention if they experience any of these symptoms.

Montelukast Aurobindo is contraindicated in individuals with known hypersensitivity to montelukast or any of the tablet’s excipients. Caution is also advised for patients with severe hepatic impairment, and it should not be used as a rescue medication for acute asthma attacks.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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